Skin/Melanoma Trials

E3612: A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV MelanomaAims: The purpose of this research study is to compare the good and bad effects of using the study drug called ipilimumab either alone or in combination with the study drug called bevacizumab. This regimen could help improve how long you are able to live with your cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach used to treat advanced melanoma. Ipilimumab is approved by the FDA at a dose of 3 mg/kg for a total of 4 doses given 3 weeks apart for metastatic melanoma that cannot all be removed or treated with surgery. Bevacizumab is not approved by the FDA to treat melanoma, and is an investigational treatment. There will be about 168 people taking part in this study. Ten of those patients will be from NorthShore University HealthSystem. Diagnosis: Unresectable Stage III or Stage IV MelanomaPrincipal Investigator: Bruce Brockstein, MD IRB Approval Number: EH14-171 Sponsor: Eastern Cooperative Oncology Group Contact: Interested patients should contact research nurse Elita Fine, RN at 847.570.2698Open to Enrollment: Yes

EA6141: A Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma Aims: The purpose of this research study is to compare any good and bad effects of giving ipilimumab, nivolumab and GM-CSF (Sargramostim) at the same time compared to just ipilimumab and nivolumab. Diagnosis: MelanomaPrincipal Investigator: Bruce Brockstein, MDIRB Approval Number: EH16-200Sponsor: ECOG-ACRINContact: Interested patients should contact research nurse Elita Fine, RN at 847.570.2698Open to Enrollment: Yes

S1404: A Phase III Randomized Trial Comparing High Dose Interferon to MK-3475 (Pembrolizumab) in Patients with High Risk Resected MelanomaAims: The purpose of this research study is to compare the good and bad effects of using the study drug called pembrolizumab to the usual treatment of interferon alfa-2b. Diagnosis: MelanomaPrincipal Investigator: Bruce Brockstein, MD IRB Approval Number: EH16-154 Sponsor: Southwest Oncology Group Contact: Interested patients should contact research nurse Elita Fine, RN at 847.570.2698Open to Enrollment: Yes

UC15-1788: A Phase II Study of Pembrolizumab and Ipilimumab Following Initial Anti-PD1/L1 AntibodyAims: The purpose of this research study is determine whether pembrolizumab in combination with ipilumumab is an effective regimen for subjects who have previously received an anti-PD1 antibody such as pembrolizumab or nivolumab.Diagnosis: MelanomaPrincipal Investigator: Bruce Brockstein, MD IRB Approval Number: EH17-086Sponsor: University of ChicagoContact: Interested patients should contact research nurse Elita Fine, RN at 847.570.2698Open to Enrollment: Yes

S1320: A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant MelanomaAims: The purpose of this research study is to compare the good and bad effects of having a break in treatment with dabrafenib and trametinib comparing to continous treatment.Diagnosis: MelanomaPrincipal Investigator: Bruce Brockstein, MD IRB Approval Number: EH17-074Sponsor: Southwest Oncology Group Contact: Interested patients should contact research nurse Elita Fine, RN at 847.570.2698Open to Enrollment: Yes

BMS CA209-357: A US Prospective Multi-Site Observational Study in Patients with Unresectable and Metastatic Melanoma: The OPTIMIZE study.Aims: The purpose of this research study is to collect information on the the treatment and management of advanced melanoma.Diagnosis: MelanomaPrincipal Investigator: Bruce Brockstein, MDIRB Approval Number: EH16-042Sponsor: Bristol-Myers- Contact: Interested patients should contact research nurse Elita Fine, RN at 847.570.2698Open to Enrollment: Yes